Kyphoplasty, Prone Position, Target Controlled Infusion of Propofol, End Tidal Carbon Dioxide
Conditions
Keywords
target controlled infusion, kyphoplasty, sedation, non-invasive etco2
Brief summary
This single-center, prospective, observational study compares target-controlled infusion (TCI) versus manually administered total intravenous anesthesia (TIVA) for sedation in patients undergoing kyphoplasty in the prone position. The primary endpoints are the incidence of hypoxic episodes (SpO₂ \< 90%) and apneic attacks. Secondary endpoints include anesthesia quality scores, integrated pulmonary index (IPI) values, total propofol consumption, time to eye opening, time to full orientation, Modified Aldrete Scores and Richmond Agitation-Sedation Scale (RASS) scores in the recovery unit, and patient and surgeon satisfaction.
Detailed description
Kyphoplasty is a minimally invasive spinal procedure commonly performed for osteoporotic vertebral compression fractures. The procedure involves balloon elevation of the collapsed vertebral body followed by injection of polymethylmethacrylate (PMMA) bone cement for stabilization. The procedure is performed in the prone position and typically involves 1-2 vertebral levels. Total intravenous anesthesia (TIVA), using combinations of propofol and remifentanil, is an alternative to inhalation anesthesia. TIVA can be administered manually or via target-controlled infusion (TCI) systems. TCI systems use pharmacokinetic models to achieve and maintain targeted plasma or effect-site concentrations. Studies in endoscopy settings have demonstrated that TCI-based sedation provides more stable sedation depth, fewer hemodynamic fluctuations, and faster recovery compared to manual administration. Kyphoplasty procedures are typically performed in elderly patients with multiple comorbidities in the prone position under fluoroscopic guidance. The prone position, while mandatory for kyphoplasty, presents significant anesthesia management challenges: limited airway access increases the risk of respiratory depression during sedation, and chest compression impairs ventilation mechanics and may reduce alveolar ventilation. Therefore, meticulous respiratory monitoring during kyphoplasty is essential. The Capnostream® device records four variables (SpO₂, respiratory rate, non-invasive EtCO₂, and heart rate) every 30 seconds via a nasal cannula and integrates them into a single unitless value called the Integrated Pulmonary Index (IPI), ranging from 1 to 10. An IPI of 4 or below requires intervention, while 8-10 represents the normal range. Additionally, bispectral index (BIS) monitoring enables objective tracking of anesthesia depth through EEG waveform analysis. This study aims to compare manual TIVA versus TCI methods regarding sedation depth, respiratory stability, hemodynamic parameters, and recovery in patients undergoing kyphoplasty in the prone position. The findings are expected to contribute to determining the optimal anesthesia approach in this patient population.
Interventions
In patients in group TCI, target-controlled propofol sedation will be administered using an elevated (opioid) model, and the target concentration will be titrated between 1-2 mcg/ml.
DEVICEnon invasive ETCO2 monitoring
The Capnostream® device records four variables (SpO₂, respiratory rate, non-invasive EtCO₂, and heart rate) every 30 seconds via a nasal cannula and integrates them into a single unitless value called the Integrated Pulmonary Index (IPI), ranging from 1 to 10. An IPI of 4 or below requires intervention, while 8-10 represents the normal range
Sponsors
Marmara University Pendik Training and Research Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
\- Age 18 years and older * ASA physical status classification I-III * Scheduled for kyphoplasty under sedation in the prone position * Provision of written informed consent
Exclusion criteria
* Known allergy to any of the study medications * ASA physical status classification IV or higher * Patients deemed unsuitable for sedation (high pulmonary risk, morbid obesity, diagnosed severe obstructive sleep apnea) * Refusal to participate or withdrawal of consent * Diagnosis of dementia or Alzheimer's disease * Communication difficulties precluding adequate assessment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| . Number of Hypoxic Episodes | from sedation initiation to end of procedure,Intraoperatively | Total number of episodes in which peripheral oxygen saturation drops below 90% during the procedure.(SpO₂ \< 90%) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anesthesia Quality Score (0-32) | from sedation initiation to end of procedure, Intraoperatively. | Assessed using the Simplified Quality of Anesthesia Scoring System (Ding \& White), evaluating motor response, hemodynamic stability, and respiratory stability. |
| Integrated Pulmonary Index (IPI) Values | Every 10 minutes intraoperatively, during sedation procedures | Composite index (1-10) integrating SpO₂, respiratory rate, EtCO₂, and heart rate measured via Capnostream® device. |
| Total Propofol Consumption | Intraoperatively, from sedation initiation to end of procedure | Total amount of propofol administered during the procedure (mg). |
| Time to Eye Opening | From end of procedure to first eye opening, up to 10 minutes | Time in minutes from end of the procedure to spontaneous eye opening. |
| Surgeon Satisfaction | end of the procedure. | Assessed on a 4-point scale: very good, good, fair, poor. |
Countries
Turkey (Türkiye)
Contacts
CONTACTdilara göçmen, asst prof
Outcome results
None listed